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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Breathing Frequency
510(k) Number K790304
Device Name PREAMPLIFIER MODULE, EKG RESPIRATION
Applicant
Abbott Medical Electronics Co.
Fort Worth,  TX 
Correspondent
Abbott Medical Electronics Co.
Fort Worth,  TX 
Regulation Number868.2375
Classification Product Code
BZQ  
Date Received02/13/1979
Decision Date 02/27/1979
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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